BEUDAMED
    FDA Recall Terminated

    Terumo Surflo Winged Infusion Set with Filter and Needle Protection (Surshield), Product Code: SV-S25FL35.

    Recall: Z-0551-2016 · Initiated November 23, 2015

    Recall

    Recall Number
    Z-0551-2016
    Event Number
    72828
    Firm
    Terumo Medical Corp
    FEI Number
    2243441
    Product Code
    MEG
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    November 23, 2015
    Posted
    December 24, 2015
    Terminated
    August 1, 2017
    Address
    2101 Cottontail Lane, Somerset, NJ, 08873-1277

    Description

    Terumo Surflo Winged Infusion Set with Filter and Needle Protection (Surshield), Product Code: SV-S25FL35.

    Reason

    Potential improper bonding between the tube and luer for certain lots of Surflo Winged Infusion Set with Filter and Needle Protection (Surshield).

    Action

    Terumo N.V. Europe notified their US Importer (Termumo Medical Corporation, Somerset, NJ) of the voluntary recall on 11/23/2015 via phone and email. Terumo Medical Corporation in turn notified their sole consignee on 11/24/2015 by email that included the manufacturers Recall Notification. The notification informed the customer of the reason for the recall; how to identify affected product; to immediately identify and quarantine any available stock; and complete and return the attached Reply Form.

    Distribution

    California

    Quantity

    80,500 units